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K Number
K992099
Device Name
BIO SPA INTELLIGENT
Manufacturer
STARBENE
Date Cleared
2002-01-18

(942 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES :

  • 1- Relaxation of Muscle Spasm
  • 2- Prevention or retardation of disuse atrophy
  • 3- Increasing local blood circulation
  • 4- Muscle re-education
  • 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and
  • 6- Maintaining or increasing range of motion
Device Description

Not Found

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for a device called "Bio Spa Intelligent." It does not contain information about acceptance criteria, study design, or performance metrics. The document is a clearance letter and an "Indications For Use" statement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).